In This Week’s Issue:
1. PCORI Blog: On Contracts: Happy Anniversary to Our Merit Reviewer Mentor Program, click here to view blog post.
2. Opinion: A Health Care Revolution Threatened, click here to view op-ed.
3. Video: Engaging Patients to Drive Innovation, click here to view the video.
4. National Journal: The Underlying Condition: Increasing Diversity in Clinical Trials, click here to view the article.
5. Politico: Is Patient Consent Always Required in Research, click here to view the article.
1. PCORI Blog: On Contracts: Happy Anniversary to Our Merit Reviewer Mentor Program, click here to view blog post.
2. Opinion: A Health Care Revolution Threatened, click here to view op-ed.
3. Video: Engaging Patients to Drive Innovation, click here to view the video.
4. National Journal: The Underlying Condition: Increasing Diversity in Clinical Trials, click here to view the article.
5. Politico: Is Patient Consent Always Required in Research, click here to view the article.
1. PCORI Blog: On Contracts: Happy Anniversary to Our Merit Reviewer Mentor Program
Last week, PCORI’s Tsahai Tafari, Suzanne Schrandt, Scott Solomon, and James Hulbert commented on The PCORI Blog regarding the merit review mentor program. Tafari is PCORI’s Senior Program Officer for Merit Review, Schrandt is PCORI’s Deputy Director for Patient Engagement, Solomon is PCORI’s Director of Contracts Management, and Hulbert is PCORI’s Pre-Award Manger. In the blog, the authors comment, “To ensure they have no unintended influence on the review process, mentors don't have access to applications. Instead, they help the patient and other stakeholder reviewers better understand the specifics of our review criteria and scoring system. They also assist reviewers in developing strategies for completing written critiques that meet our high standards. Finally, mentors prepare reviewers for our in-person review panel meetings, so their perspectives are effectively communicated to the other panel members and, ultimately, to applicants.” Click here to view the blog post.
2. Opinion: A Health Care Revolution Threatened
In an op-ed published in the Orange County Register, Center for Medicine in the Public Interest (CMPI) President Peter Pitts comments, “Uncle Sam recently started up a ‘comparative effectiveness’ research wing. This work is designed to determine if new, more expensive drugs are worth covering in programs like Medicare and Medicaid. The fundamental flaw of comparative effectiveness research is that there is no such thing as an “average” patient. A treatment that might not make much of a difference for most patients could prove to be a life-saver for others. If effectiveness research leads to more constrictive public insurance policies, enrollees that could benefit from advanced personalized drugs will be forced to pay for them on their own. Most simply can't afford to do that. In effect, the government will be denying them access to this revolution in medicine.” Click here to view the op-ed.
3. Video: Engaging Patients to Drive Innovation
In a video produced by a PIPC Member, the Association of Clinical Research Organizations (ACRO), a leading panel of experts discusses how to improve patient involvement in clinical trials. The video features experts including Pamela Tenaerts, Executive Director of the Clinical Trials Transformation Initiative, Patricia Leuchten, President and CEO of the Avoca Group Inc., Dalvir Gill, CEO of TransCelerate Biopharma, Luke Williams, professor of innovation and author of "Disrupt", and John Lewis, Vice President of ACRO. Click here to view the video.
4. National Journal: The Underlying Condition: Increasing Diversity in Clinical Trials
According to an op-ed published in National Journal, “Studies have shown that genetic makeup can impact how individuals respond to medicines, so clinical testing of the effectiveness of potential new treatments should accurately reflect the patient population that will eventually take them if successfully developed. Currently, this is not always the case. The FDA reports that even though African-Americans are 12 percent of the U.S. population, they make up only 5 percent of clinical-trial participants. Hispanics represent 16 percent of the U.S. population, but only 1 percent of clinical-trial participants. […] Inclusion of participants with diverse ethnic and racial backgrounds can further research and help find better ways to fight diseases that disproportionately impact these populations.” Click here to view the article.
5. Politico: Is Patient Consent Always Required in Research
According to an article published in the New England Journal of Medicine, full informed consent for patients is not ethically required for some types of health research. The authors argue that in some cases, a consent process is unnecessary from the standpoint of protecting patients and could be potentially harmful to patients when it functions as an obstacle to gaining new knowledge that can improve quality of care. As reported by Politico, the authors “write that consent is not a ‘morally necessary condition’ for all medical studies. ‘In a mature learning healthcare system with ethically robust oversight policies and practices, some randomized CER studies may justifiably proceed with a streamlined consent process and others may not require patient consent at all,’ they state. And while such a system is still in the future, they stress the importance of moving from a single approach to informed consent, so that; higher-risk research gets the focused attention it deserves and less consequential research can proceed more rapidly.’” Click here to view the article.
Last week, PCORI’s Tsahai Tafari, Suzanne Schrandt, Scott Solomon, and James Hulbert commented on The PCORI Blog regarding the merit review mentor program. Tafari is PCORI’s Senior Program Officer for Merit Review, Schrandt is PCORI’s Deputy Director for Patient Engagement, Solomon is PCORI’s Director of Contracts Management, and Hulbert is PCORI’s Pre-Award Manger. In the blog, the authors comment, “To ensure they have no unintended influence on the review process, mentors don't have access to applications. Instead, they help the patient and other stakeholder reviewers better understand the specifics of our review criteria and scoring system. They also assist reviewers in developing strategies for completing written critiques that meet our high standards. Finally, mentors prepare reviewers for our in-person review panel meetings, so their perspectives are effectively communicated to the other panel members and, ultimately, to applicants.” Click here to view the blog post.
2. Opinion: A Health Care Revolution Threatened
In an op-ed published in the Orange County Register, Center for Medicine in the Public Interest (CMPI) President Peter Pitts comments, “Uncle Sam recently started up a ‘comparative effectiveness’ research wing. This work is designed to determine if new, more expensive drugs are worth covering in programs like Medicare and Medicaid. The fundamental flaw of comparative effectiveness research is that there is no such thing as an “average” patient. A treatment that might not make much of a difference for most patients could prove to be a life-saver for others. If effectiveness research leads to more constrictive public insurance policies, enrollees that could benefit from advanced personalized drugs will be forced to pay for them on their own. Most simply can't afford to do that. In effect, the government will be denying them access to this revolution in medicine.” Click here to view the op-ed.
3. Video: Engaging Patients to Drive Innovation
In a video produced by a PIPC Member, the Association of Clinical Research Organizations (ACRO), a leading panel of experts discusses how to improve patient involvement in clinical trials. The video features experts including Pamela Tenaerts, Executive Director of the Clinical Trials Transformation Initiative, Patricia Leuchten, President and CEO of the Avoca Group Inc., Dalvir Gill, CEO of TransCelerate Biopharma, Luke Williams, professor of innovation and author of "Disrupt", and John Lewis, Vice President of ACRO. Click here to view the video.
4. National Journal: The Underlying Condition: Increasing Diversity in Clinical Trials
According to an op-ed published in National Journal, “Studies have shown that genetic makeup can impact how individuals respond to medicines, so clinical testing of the effectiveness of potential new treatments should accurately reflect the patient population that will eventually take them if successfully developed. Currently, this is not always the case. The FDA reports that even though African-Americans are 12 percent of the U.S. population, they make up only 5 percent of clinical-trial participants. Hispanics represent 16 percent of the U.S. population, but only 1 percent of clinical-trial participants. […] Inclusion of participants with diverse ethnic and racial backgrounds can further research and help find better ways to fight diseases that disproportionately impact these populations.” Click here to view the article.
5. Politico: Is Patient Consent Always Required in Research
According to an article published in the New England Journal of Medicine, full informed consent for patients is not ethically required for some types of health research. The authors argue that in some cases, a consent process is unnecessary from the standpoint of protecting patients and could be potentially harmful to patients when it functions as an obstacle to gaining new knowledge that can improve quality of care. As reported by Politico, the authors “write that consent is not a ‘morally necessary condition’ for all medical studies. ‘In a mature learning healthcare system with ethically robust oversight policies and practices, some randomized CER studies may justifiably proceed with a streamlined consent process and others may not require patient consent at all,’ they state. And while such a system is still in the future, they stress the importance of moving from a single approach to informed consent, so that; higher-risk research gets the focused attention it deserves and less consequential research can proceed more rapidly.’” Click here to view the article.